The Recall Desk
HighFDA (Devices)·Z-0687-2020·Announced 2019-12-25

Southwest Technologies Recalls Mold-Contaminated Elasto-Gel Wound Dressings

Southwest Technologies Inc is recalling Elasto-Gel Absorbent Wound Dressings due to potential mold contamination. The affected sterile dressings were distributed to nine states.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves potential mold contamination in a sterile medical device. While no specific injuries are reported in the source text, the risk of infection from a contaminated sterile product places this in the High severity category per the rubric for risk-of-harm products.

Plain-English summary

Southwest Technologies Inc is recalling Elasto-Gel Absorbent Wound Dressings, Item DR8000, because the product may be contaminated with mold. The recalled product consists of sterile, bacteriostatic dressings, 4 inches by 4 inches, sold in retail boxes of five. The specific lot number is 1917802, and the UPC is 45713-58000.

The recall involves 3,260 units, which equates to 652 retail boxes. The product was distributed to California, Georgia, Illinois, Kansas, New York, Ohio, Tennessee, Texas, and Virginia.

Consumers who have purchased this product should stop using it immediately and contact Southwest Technologies Inc for further instructions or a refund. The FDA has classified this as a Class II recall, indicating that use of the product could cause temporary or medically reversible health consequences.

The recalled product

Product
Elasto-Gel Absorbent Wound Dressing, Item DR8000. 5 Dressings 4" x 4". Sterile. UPC 45713-58000 Bacteriostatic

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • Lot 1917802

Distribution

Distributed in 9 states: